FDA 510(k)

WELLlife COVID-19 Antigen Test Rx

Número K: K251289 · 2025-10-22

RequerenteGuangzhou Wondfo Biotech Co., Ltd.

Data da decisão2025-10-22

Código do produtoQVF

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

WELLlife COVID-19 Antigen Test Rx is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251289. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WELLlife COVID-19 Antigen Test Rx?

WELLlife COVID-19 Antigen Test Rx is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K251289.

When did WELLlife COVID-19 Antigen Test Rx receive FDA 510(k) clearance?

WELLlife COVID-19 Antigen Test Rx received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251289.

Who is the listed applicant for WELLlife COVID-19 Antigen Test Rx?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLlife COVID-19 Antigen Test Rx?

The FDA product code for WELLlife COVID-19 Antigen Test Rx is QVF.

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Outros registros que listam Guangzhou Wondfo Biotech Co., Ltd. como candidato(a)

K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx K182701Wondfo T-Cup Multi-Drug Urine Test Cup

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Fonte oficial

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